FDA Clears Ascletis' IND for ASC50, a Novel Oral IL-17 Inhibitor for Psoriasis Treatment
Key Insights
The U.S. FDA has cleared Ascletis Pharma's IND application for ASC50 (search), an oral small molecule IL-17 (search) inhibitor, allowing Phase I trials in mild-to-moderate plaque psoriasis (search) patients to begin in Q3 2025.
Preclinical data shows ASC50 (search) demonstrates superior pharmacokinetics with higher drug exposure, longer half-life, and lower clearance compared to other oral IL-17 (search) inhibitors in development, positioning it as a potential best-in-class treatment.
ASC50 (search) represents Ascletis' first immunology candidate developed using their Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) Platform, marking a significant milestone in their autoimmune disease portfolio.
Ascletis Pharma Inc. (search) (HKEX:1672) announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ASC50 (search), an oral small molecule inhibitor targeting interleukin-17 (IL-17 (search)), for the treatment of mild-to-moderate plaque psoriasis (search).
The Hong Kong-based biopharmaceutical company plans to initiate a Phase I clinical trial in the third quarter of 2025. The study will be a randomized, double-blind, placebo-controlled trial conducted at multiple sites across the United States.
Promising Preclinical Profile
ASC50 (search) was discovered and developed entirely in-house by Ascletis and represents the company's first oral small molecule drug candidate in immunology arising from their Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) Platform.
Preclinical data from non-human primate studies demonstrated that ASC50 (search) has several advantages over an existing oral small molecule IL-17 (search) inhibitor currently in clinical development:
- Higher drug exposure following oral administration
- Longer half-life
- Lower clearance rate
Additionally, ASC50 (search) showed strong efficacy in psoriasis (search) animal models, supporting its potential as a best-in-class once-daily oral treatment for psoriasis.
Targeting a Validated Pathway
IL-17 (search) is a well-established therapeutic target for psoriasis (search) and other autoimmune and inflammatory diseases. While several injectable monoclonal antibodies targeting IL-17 or its receptor (including ixekizumab, secukinumab, and brodalumab) have been approved for psoriasis treatment, oral small molecule inhibitors of this pathway remain rare.
The development of an effective oral IL-17 (search) inhibitor could provide significant advantages for patients who prefer oral administration over injections, potentially improving treatment adherence and quality of life.
Company Leadership Perspective
"We are excited and encouraged by the preclinical data of ASC50 (search) as it is the first oral small molecule drug candidate in immunology arisen from our Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) Platform," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis.
"The IND clearance of ASC50 (search) marks a new milestone for Ascletis in autoimmune and inflammatory diseases. We are continuing to work on differentiated agents including oral drugs and once-monthly or less frequent subcutaneously injectables to address unmet medical needs in multiple key therapeutics areas."
Expanding Therapeutic Portfolio
Ascletis is an R&D-driven biotech company covering the entire value chain from discovery and development to GMP manufacturing. The company has been primarily focused on metabolic diseases but is now expanding its portfolio to include treatments for autoimmune and inflammatory conditions.
The advancement of ASC50 (search) into clinical trials represents a significant step in this strategic expansion, leveraging the company's AI-driven drug discovery capabilities to address unmet needs in the treatment of psoriasis (search) and potentially other inflammatory disorders.
About Psoriasis
Psoriasis (search) is a chronic inflammatory skin condition affecting approximately 125 million people worldwide. Plaque psoriasis (search), the most common form, is characterized by raised, red patches covered with a silvery white buildup of dead skin cells. The condition can significantly impact quality of life and is associated with several comorbidities, including psoriatic arthritis (search), cardiovascular disease, and metabolic syndrome.
While current biologic treatments targeting IL-17 (search) have shown high efficacy, the development of oral options could address important treatment gaps and patient preferences in the management of this chronic condition.